scholarly journals Evolution of the Stabilis® Database: Creation of a Level of Evidence for Stability Studies

2018 ◽  
Vol 3 (1) ◽  
pp. 3-12 ◽  
Author(s):  
Elise D’Huart ◽  
Pauline Lider ◽  
Jean Vigneron ◽  
Béatrice Demoré
Keyword(s):  
Analytical Method ◽  
Antiviral Drugs ◽  
Stability Study ◽  
Antifungal Drugs ◽  
Quality Level ◽  
Stability Studies ◽  
Level Of Evidence ◽  
Stability Data ◽  
The Stability

AbstractBackgroundStabilis®is an international database on stability and compatibility of drugs. The stability data comes mainly from publications of pharmaceutical journals. As the quality of the published stability studies is not equivalent, the objective of this work was to propose a level of evidence for the physico-chemical stability studies selected for the database.MethodsAt first, we evaluated the main pharmacological class consulted by the users. This work was then divided into 5 steps: (1) updating of the criteria to validate a stability study, (2) creating a grid rating articles, (3) rating of the articles of stability studies for anticancer, antifungal and antiviral drugs by 2 evaluators, (4) creation of new screens in the database to enter rating, to visualize the pictograms and commentaries by the users, (5) creation of a guideline to explain the different levels of evidence.ResultsThe main pharmacological class consulted by Stabilis®users is the anticancer drugs and then antiinfectives. We have selected anticancer, antifungal and antiviral drugs for our study. Two hundred and forty publications were evaluated. The highest level attributed was A for anticancer and antifungal drugs and C for antiviral drugs. This difference can be explained by the fact that the majority of publications about antiviral drugs were older.The most frequent anomalies in the rating of articles were an incomplete or imperfect validation of the analytical method (high value of the coefficient of variation) and a defect in the evaluation of the stability indicating capacity.It must be noted that the level of evidence is not the quality level of the analytical method but the mixture of the quality of the method validation and of the results. This aspect was a choice of the Stabilis®team and seems important because the security of the patient is impacted by both aspects.ConclusionsThis new function contributes to help the Stabilis®users to evaluate the stability data published and to take a decision for their use in daily practice. This function will be progressively extended to other pharmacological classes of injectable drugs and then for non-injectable preparations.

scholarly journals Bio-analytical Approach for Stability Studies of Bendroflumethiazide Materials

2021 ◽  
pp. 195-203
Author(s):  
B. Veeraswami ◽  
V. M. K. Naveen
Keyword(s):  
Stability Study ◽  
Stability Studies ◽  
Dry Extract ◽  
Long Term Stability ◽  
Analytical Stability ◽  
Ich Guidelines ◽  
The Stability ◽  
Efficacy Prediction

In this paper a comprehensive study of stability related, and evidence based best practices of Bio-analytical stability on Bendroflumethiazide drug samples are studied. The proposed approach is very significant and essential for the drugs development process address the specify the acceptancy, purity, efficacy, prediction of strength and quality of the drugs. The stability study constituents several methods like Bench-Top, Auto-sampler, Freeze-Thaw, Dry-extract, Wet-extract, Short-term, long-Term stability studies at relative intervals results the complete stability information about the drug under the proposed and validated method. There ported out comes of this methos shows this drug have good stability according to ICH guidelines.

scholarly journals FORMULATION, CHARACTERIZATION AND STABILITY STUDY OF FAST DISSOLVING THIN FILM CONTAINING ASTAXANTHIN NANOEMULSION USING HYDROXYPROPYLMETHYL CELLULOSE POLYMER

2021 ◽  
pp. 17-22
Author(s):  
LUSI NURDIANTI ◽  
IYAN SOPYAN ◽  
TAOFIK RUSDIANA
Keyword(s):  
Thin Film ◽  
Mechanical Characteristics ◽  
Storage Conditions ◽  
Stability Study ◽  
Matrix System ◽  
Stability Studies ◽  
Casting Method ◽  
Hydroxypropylmethyl Cellulose ◽  
The Stability ◽  
Physical And Mechanical Characteristics

Objective: The present study was conducted to formulate and characterize the thin film containing astaxanthin nanoemulsion (TF-ASN) using Hydroxypropylmethyl Cellulose (HPMC) polymer as a film matrix system. The stability studies in different storage conditions were also performed. Methods: Astaxanthin nanoemulsion (As-NE) was prepared by using self-nanoemulsifying method, followed by incorporation into the HPMC matrix system by solvent casting method to forming TF-ASN. Evaluation of TF-ASN was performed by physical and mechanical characterizations. Stability study was carried out in both of accelerated (temperature of 40±2 °C/75±5% RH) and non-accelerated (at ambient temperature) conditions. Assay of astaxanthin in individual TF-ASN was determined compared to pure astaxanthin. Results: TF-ASN had good physical and mechanical characteristics that suitable for intraoral administration. Conclusion: For the study of stability under different storage conditions, it was proven that nanoemulsion form was packed in a HPMC matrix could enhance the stability of the astaxanthin.

scholarly journals Stability study of rock slope in fractured quartzite at right side of spillway, Middle Marsyangdi Hydroelectric Project, Nepal

2003 ◽  
Vol 28 ◽  
Author(s):  
Kaustubh Mani Nepal ◽  
Roger Olsson
Keyword(s):  
Rock Slope ◽  
Stability Study ◽  
Cut Slope ◽  
Stability Studies ◽  
Hydroelectric Project ◽  
The Stability ◽  
The Right ◽  
Cut Slopes

A 120 m long and 68 m high rock cut slope is designed at the right side of spillway of Middle Marsyangdi Hydroelectric Project. This paper describes the stability studies performed for the rock cut slopes in jointed quartzite for foundation of spillway.

scholarly journals Preservatives Stability: Stability Study of Parabens under Different Conditions of Stress Degradation

2020 ◽  
Vol 11 (3) ◽  
pp. 4187-4194
Author(s):  
Ismail Bennani ◽  
Madiha Alami Chentoufi ◽  
Miloud El Karbane ◽  
Ibrahim Sbai El Otmani ◽  
Amine Cheikh ◽  
...  
Keyword(s):  
Extreme Values ◽  
Stability Study ◽  
Wide Field ◽  
Direct Influence ◽  
Light Conditions ◽  
Influence Of Temperature ◽  
Stress Degradation ◽  
Quality Of Products ◽  
The Stability

Preservatives are used in a wide field of application to maintain the quality of products. They are used to deal with the chemical, physical and microbiological problems and the constraints of the development of several formulations. In this work, we tested the stability of antimicrobial preservatives which are the parabens under different stress degradation conditions to evaluate their degree of effectiveness. The tested parabens were incubated in different solutions at different pH, Temperatures, light conditions, and presence or absence of sucrose in solution (create a medium similar of syrups). The HPLC was used for the assay, by a validated method for the parabens assay and the statistical analysis of the data is carried out by JMP software. The results show a direct influence of temperature and pH on the level of parabens, while the influence of light remains negligible. The increase in temperature gives a degree of immunity of parabens levels, especially with the extreme values of pH. This study is one of the first studies of forced decomposition of parabens carried out under the various conditions suggested. The results give an idea of the stability profile of the tested parabens and suggest a model of the conditions of conservation and use of these products in different domains and under different conditions.

scholarly journals Kualitas Ekstrak Karaginan Dari Rumput Laut “Kappaphycus alvarezii” Hasil Budidaya Di Perairan Pantai Kartini Dan Pulau Kemojan Karimunjawa Kabupaten Jepara

2017 ◽  
Vol 6 (2) ◽  
pp. 88 ◽  
Author(s):  
Endang Supriyantini ◽  
Gunawan Widi Santosa ◽  
Agus Dermawan
Keyword(s):  
Kappaphycus Alvarezii ◽  
Chemical Properties ◽  
Ester Group ◽  
Gel Strength ◽  
Quality Level ◽  
Spectra Analysis ◽  
Sulphate Content ◽  
The Stability ◽  
Kappa Carrageenan

Karaginan merupakan senyawa hidrokoloid yang diekstraksi dari rumput laut merah jenis Kappaphycus alvarezii. Karaginan dapat digunakan untuk meningkatkan kestabilan bahan pangan baik yang berbentuk suspensi (dispersi padatan dalam cairan), emulsi (dispersi gas dalam cairan). Tujuan dari penelitian ini adalah mengetahui Kualitas ekstrak karaginan hasil ekstraksi rumput laut K. alvarezii dari dua lokasi sampling yang berbeda. Penelitian ini dilaksanakan pada bulan Agustus 2015 sampai bulan Januari 2016, di perairan Pantai Kartini, Jepara dan peraian Kemojan Karimunjawa, Jepara. Hasil penelitian menunjukkan analisis spektra FTIR produk telah memenuhi spesifikasi karaginan standar karena gugus-gugus fungsi yang terdapat pada spektrum sampel yang dihasilkan sama seperti gugus pada kappa karaginan yaitu gugus ester sulfat, OH, ikatan glikosidik. Hasil analisis sifat fisik-kimia karaginan (rendemen, kadar air, kadar abu, kadar sulfat, viskositas, dan kekuatan gel) yang paling baik yaitu karaginan dari perairan Kemojan Karimunjawa dibandingkan karaginan Pantai Kartini. Kadar sulfat Pantai Kartini dan Kemojan Karimunjawa masih dibawah kadar mutu yaitu 15-40 %, Sedangkan kekuatan gel kedua perairan yaitu Kemojan Karimunjawa 78,57 g.cm-2 dan Pantai kartini 61,86 g.cm-2 masih jauh di bawah baku mutu yaitu 685,50 g.cm2. Carrageenan is a hydrocolloid compounds extracted from red seaweed types Kappaphycus alvarezii. Carrageenan can be used to improve the stability of food in the form of suspension or emulsions. The purpose of this study was to determine the quality of the extract of carrageenan extracted from K. alvarezii at two different sampling locations. This research was conducted in August, 2015 and January, 2016. Samples of seaweed obtained from two different waters, namely Kartini Beach and Kemojan Karimunjawa Island, bolt at jepara regency. The results showed the FTIR spectra analysis of the product met the specifications for a standard carrageenan functional groups contained in the sample spectrum as expressed in clusters of kappa carrageenan namely sulphate ester group , OH , glycosidic bond. The results of analysis  of the physical-chemical properties of carrageenan ( yield, moisture content , ash content , sulphate content , viscosity and gel strength ) the best quality of carragenan was obtained from carrageenophyte taken from Kemojan Karimunjawa Island, although sulphate content from two different waters was under quality level at 15 – 40%, while the  gel strength kartini 61.86 g.cm-2 and Kemojan 78.57 g.cm-2 both were still far below the of carrageenophyte quality at 685.50 g.cm-2.

scholarly journals An investigation of reconstituted terlipressin infusion stability for use in hepatorenal syndrome

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Thi Ngoc Nhieu Bui ◽  
Su Sandar ◽  
Giuseppe Luna ◽  
Jasmine Beaman ◽  
Bruce Sunderland ◽  
...  
Keyword(s):  
Hepatorenal Syndrome ◽  
Colour Change ◽  
First Line ◽  
Term Survival ◽  
Advanced Cirrhosis ◽  
Elimination Half ◽  
Stability Data ◽  
The Stability

AbstractHepatorenal syndrome (HRS) is a fatal complication of renal dysfunction associated with ascites, liver failure and advanced cirrhosis. Although the best option for long-term survival is liver transplantation, in the critical acute phase, vasoconstrictors are considered first-line supportive agents. Terlipressin is the most widely used vasoconstrictor globally but owing to its short elimination half-life, it is usually administered six hourly by slow intravenous bolus injection. This requires patients to remain in hospital, increasing hospital bed costs and affecting their quality of life. An alternative option for administration of terlipressin is as a continuous infusion using an elastomeric infusor device in the patient’s home. However, stability data on terlipressin in elastomeric infusor devices is lacking. This research aimed to evaluate the stability of terlipressin reconstituted in infusor devices for up to 7 days at 2–8 °C and subsequently at 22.5 °C for 24 h, to mimic home storage and administration temperatures. We report that terlipressin was physically and chemically stable under these conditions; all reconstituted infusor concentrations retained above 90% of the original concentration over the test conditions. No colour change or precipitation in the solutions were evident.

EVALUATION OF SHELF LIFE OF BHALLATAKA TAILA (OIL)

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (06) ◽  
pp. 36-41
Author(s):  
Anu Ruhila ◽  
◽  
Pramod R. Yadav ◽  
Galib R ◽  
Pradeep K. Prajapati
Keyword(s):  
Shelf Life ◽  
Fatty Acid Content ◽  
Stability Study ◽  
Polyunsaturated Fatty Acid Content ◽  
Accelerated Stability ◽  
Physico Chemical ◽  
Current Scenario ◽  
The Government ◽  
The Stability

Bhallataka Taila (Oil) is extracted with the help of Patala Yantra. It is one of the important formulations in Ayurveda pharmaceutics. Shelf life for various dosage forms are described in Ayurveda classics. In the current scenario, the amendment of Rule No. 161-B of the Drugs and Cosmetic Act 1940, specifies the maximum shelf life of Ayurvedic formulations. However, there is a lack of shelf life data for individual for-mulations. Thus, the present study is aimed to evaluate the shelf life of Bhallataka Taila (Oil). Bhallataka Taila (Oil) was extracted following classical guidelines. The sample was subjected to an accelerated stability study maintaining the temperature and humidity 40 +- 2 0C and 75 +- 5 %, respectively. Physico-chemical parameters were analysed at the initiation of the study and at an interval of 1, 3 and 6 months to check the degradation levels in the formulation. Tests for microbial limit and heavy metals were also conducted for the safety and quality of the product. On extrapolating the observations, the shelf life for Bhallataka Taila (Oil) was found to be 4.89 years, which exceeds the shelf life mentioned for Taila (Oil) in official gazettes of the Government of India. This oil preparation does not incorporate any liquid media such as Swarasa (Juice), Kwatha (decoction), etc. as required in any Taila Preparation, resulting in low degradation rate. The oil is rich in PUFA (polyunsaturated fatty acid) content and tocopherols, which may contribute to the stability of the oil.

Stability of phencyclidine and Amphetamines in Urine Specimens

1991 ◽  
Vol 37 (12) ◽  
pp. 2141-2142 ◽  
Author(s):  
R Hughes ◽  
A Hughes ◽  
B Levine ◽  
M L Smith
Keyword(s):  
Room Temperature ◽  
Drugs Of Abuse ◽  
Stability Study ◽  
The Other ◽  
Gas Chromatography Mass Spectrometry ◽  
Stability Data ◽  
The Stability ◽  
Proper Interpretation ◽  
Drug Free ◽  
Urine Specimens

Abstract Knowledge about the stability of drugs in biological specimens can be critical to the proper interpretation of results. Stability of drugs of abuse in biological specimens has been recently reviewed (1). Two drugs for which limited stability data have been published are phencyclidine (PCP) and amphetamine (AMP)/methamphetamine (MA). Therefore, we undertook a stability study of these drugs in urine specimens. Urine samples from five drug-free individuals were fortified with PCP, AMP, and MA at three concentrations. These specimens were divided into aliquots; one was stored at room temperature (25 °C), the other in the refrigerator (4 °C). Over a six-month period, aliquots of each specimen were quantified by gas chromatography-mass spectrometry (2). A known control was analyzed with each batch; results were within 10% of the expected value.

scholarly journals Stabilizing effect of chitosan-poly vinyl alcohol complex on simvastatin loaded nanoformulation

2019 ◽  
Vol 10 (3) ◽  
pp. 2265-2279
Author(s):  
Irisappan Sarathchandiran ◽  
Nandakumar Selvasudha ◽  
Kailasam Koumaravelou ◽  
Kandasamy Ruckmani
Keyword(s):  
High Performance ◽  
Freezing Temperature ◽  
Simulation Method ◽  
Stability Study ◽  
Poly Vinyl Alcohol ◽  
Forced Degradation ◽  
Stability Studies ◽  
Drug Molecules ◽  
Accelerated Stability ◽  
The Stability

Biopolymers are attractive new and general means of presenting more stable drug delivery system. This is accomplished by encapsulation of polymers to respective drug molecules which offer formation of bonds between them.  In this work, chitosan-coated simvastatin nanoformulation was formulated using a method named solvent evaporation technique, and various stability studies were performed. The steadiness of preparation was evaluated by accelerated stability method and forced degradation method. High-performance thin-layer chromatography (HPTLC) was utilized to detect the degradant present in formulation after subjecting it in different stress condition. Simulated annealing process for the prediction of nanoformulation stability was also performed. The accelerated stability study was performed at three altered temperature conditions, (i.e.) accelerated temperature (40 ± 2 °C/75 ± 5% RH), room temperature (25 ± 2 °C/60%) ± 5% RH, and freezing temperature (4°C) and change in drug content, solubility, % cumulative drug release, moisture content and molecular weight were calculated. Standard sample and nanoformulation were exposed to different stress conditions (thermal, base, acid, and light). Finally, the percentage of decomposition was calculated by HPTLC method. All stability studies, along with the simulation method, represented the stability of simvastatin in nanoformulation.  Establishment of adequate shelf life also was achieved. This work evidenced the extensive stability offered by chitosan polymers to the prodrug simvastatin. Also, give insight when the problem of poor stability of drug molecules limits its practical applicability.

FORMULATION AND STANDARDIZATION OF AVALEHA PREPARATION FROM BENINCASA HISPIDA

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (06) ◽  
pp. 69-72
Author(s):  
S. V Patil ◽  
◽  
S. S. Patil ◽  
N. R. Inamdar ◽  
V. A Mahajan ◽  
...  
Keyword(s):  
Physicochemical Parameters ◽  
Stability Study ◽  
Control Procedure ◽  
Scientific Quality ◽  
Chronic Respiratory Diseases ◽  
Benincasa Hispida ◽  
Total Reducing Sugars ◽  
The Stability ◽  
Evaluation Parameters

Standardization of Ayurvedic formulation is essential in order to assess the quality of drugs. Avaleha is “a semisolid preparation which is prepared by reboiling of decoction etc., till it solidifies and attains signs of proper cooking and consistency. The present study deals with standardization of Avaleha from Benincasa hispida , known to be effective in caugh and chronic respiratory diseases. Avaleha formulation was prepared by reported traditional method of Ayurveda. Formulation was standardized by modern scientific quality control procedure for the finished products. Standardization of Avaleha was achieved by organoleptic study and by studing physicochemical parameters such as pH, TLC, Loss on drying, Extractive values, ash value, total reducing sugars and stability study. The results showed that the physicochemical parameters were well within the standard limits and the values could be used to establish and formulate procedures for standardization and quality controll of these ayurvedic formulations. The study revealed that the standardization parameters could be used at commercial level for such formulations. Also comparison with the marketed formulation with satisfactory evaluation parameters justifies the stability of the method.

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